College of Medical Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
RTI International, 3040 Cornwallis Rd., Durham, NC, 27709, USA.
Reprod Health. 2018 Jun 27;15(1):116. doi: 10.1186/s12978-018-0555-y.
With nearly 15 million annual preterm births globally, preterm birth is the most common cause of neonatal death. Forty to 60 % of neonatal deaths are directly or indirectly associated with preterm mortality. As countries aim to meet the Sustainable Development Goals to reduce neonatal mortality, significant reductions in preterm mortality are needed. This study aims to identify the common causes of preterm illness and their contribution to preterm mortality in low-resource settings. This article will describe the methods used to undertake the study.
This is a prospective, multi-centre, descriptive clinical study. Socio-demographic, obstetric, and maternal factors, and clinical and laboratory findings will be documented. The major causes of preterm mortality will be identified using clinical, laboratory, imaging, and autopsy methods and use the national Ethiopian guidelines on management of preterm infants including required investigations to reach final diagnoses. The study will document the clinical and management protocols followed in these settings. The approach consists of clinical examinations and monitoring, laboratory investigations, and determination of primary and contributory causes of mortality through both clinical means and by post-mortem examinations. An independent panel of experts will validate the primary and contributory causes of mortality. To obtain the estimated sample size of 5000 preterm births, the study will be undertaken in five hospitals in three regions of Ethiopia, which are geographically distributed across the country. All preterm infants who are either born or transferred to these hospitals will be eligible for the study. Three methods (last menstrual period, physical examination using the New Ballard Score, and ultrasound) will be used to determine gestational age. All clinical procedures will be conducted per hospital protocol and informed consent will be taken from parents or caretakers prior to their participation in the study as well as for autopsy if the infant dies.
This study will determine the major causes of death and illness among hospitalized preterm infants in a low-resource setting. The result will inform policy makers and implementers of areas that can be prioritized in order to contribute to a significant reduction in neonatal mortality.
全球每年约有 1500 万例早产儿，早产是新生儿死亡的最常见原因。40%至 60%的新生儿死亡直接或间接与早产死亡有关。随着各国努力实现可持续发展目标以降低新生儿死亡率，需要大幅降低早产死亡率。本研究旨在确定低资源环境中早产疾病的常见原因及其对早产死亡的影响。本文将介绍开展该研究的方法。
这是一项前瞻性、多中心、描述性临床研究。将记录社会人口统计学、产科和产妇因素以及临床和实验室发现。将使用临床、实验室、影像学和尸检方法确定早产死亡的主要原因，并使用国家埃塞俄比亚早产儿管理指南，包括所需的调查来得出最终诊断。研究将记录这些环境中遵循的临床和管理方案。该方法包括临床检查和监测、实验室检查以及通过临床手段和尸检确定死亡的主要和次要原因。一个独立的专家小组将验证死亡的主要和次要原因。为了获得估计的 5000 例早产婴儿样本量，该研究将在埃塞俄比亚三个地区的五家医院进行，这些医院在地理上分布在全国范围内。所有在这些医院出生或转来的早产儿都有资格参加该研究。将使用三种方法（末次月经、使用新 Ballard 评分的体格检查和超声）来确定胎龄。所有临床程序都将按照医院方案进行，如果婴儿死亡，将在父母或照顾者参与研究之前征得他们的同意，并征得尸检同意。
本研究将确定低资源环境中住院早产儿死亡和患病的主要原因。研究结果将为决策者和实施者提供信息，确定可以优先考虑的领域，以有助于大幅降低新生儿死亡率。
